This invention relates to closure containers for single dose disposable pharmaceutical delivery systems. The system has particular advantage for battlefield applications, mass immunizations in underdeveloped areas of the world and other general medical applications currently being serviced by pre-filled syringes.
During World War II Squibb, now Bristol-Myers Squibb, developed the disposable morphine Syrette®. It consisted of a small tube of morphine with an attached hypodermic needle. Medical personnel first had to break a seal with a small needle. The morphine was administered by piercing the patient's skin with the needle and then squeezing the tube.
A number of prior art patents for a disposable single dose dispenser utilize a moveable needle to puncture the container holding the pharmaceutical including U.S. Pat. Nos. 2,676,591; 2,687,727; 2,693,183; 3,192,925 and 4,883,473. The present invention does not utilize a moveable needle to puncture the container holding the pharmaceutical.
U.S. Pat. No. 2,618,263 for a “Disposable Single-Use Syringe” is a disposable, single use, prefilled unit dose pharmaceutical delivery system; however, the structural design is different from the present invention. In the '263 Patent, the ampoule is easily moved by a finger so that the needle punctures the ampoule, whereupon with further pressure being exerted on the ampoule, the contents thereof is expressed through the needle for the intended function of the syringe. The needle in the present invention is straight and the needle in the '263 Patent is not.
U.S. Pat. No. 3,736,933 is a “Burstable Seamed Hypodermic Applicator.” This prior art patent does not show a single dispensing apparatus with a single cap. Rather, the '933 Patent discloses a plurality of dispensing applicators in a single elongate shield to receive and cap multiple needles. In other words, this patent discloses a package with several dispensing applicators that can be selectively withdrawn from the single elongate shield/cap. The present invention uses a single shield/cap for each dispensing apparatus.
U.S. Pat. No. 4,548,601 is a “Prepackaged, Injectable Pharmaceutical and Hypodermic Needle Combination.” The combination is a disposable, single use, prefilled unit dose pharmaceutical delivery system; however, the structural design is different from the present invention. In the '601 Patent, “the injectable medication is contained within a substantially non-resilient, highly flexible sack or inner container which is indirectly compressed, pneumatically, by means of a resilient, comparatively rigid outer container. Manual collapsing pressure or squeezing of the outer container serves, in successive operations, to completely discharge the contents of the inner container through a cannulae, thereby injecting its full dose.” The present invention does not use the pneumatic pump of this prior art patent; instead, the present invention relies on manual pressure of the thumb and forefinger to discharge the pharmaceutical from the bladder. This prior art patent discloses a rupture seal, but no fill port.
U.S. Pat. No. 4,955,871 is a “Single-Use Disposable Syringe” that is prefilled unit dose pharmaceutical delivery system; however, the structural design is different from the present invention. The '871 Patent is designed to allow aspiration for intramuscular and intravenous injections whereas the present invention is not designed for aspiration. The '871 Patent is designed to create negative pressure in a reservoir means 46 formed from a pair of sheets 38a and 38b. The bladder of the present invention is not designed to create negative pressure. The present invention uses a needle seal that is ruptured by pressure. The '871 Patent uses the sharp end of the needle to penetrate the nozzle membrane 22. The '871 Patent discloses a fill port 58 for the reservoir 46, but no rupture seal.
U.S. Pat. No. 5,019,048 is a “Unit Dose Syringe with Rotatable Needle.” This prior art patent discloses a disposable, single use, prefilled unit dose pharmaceutical delivery system; however, the structural design is different from the present invention. FIGS. 7 and 8 show an embodiment wherein a needle 55 is connected to a plastic squeeze bag 56 by an unstructured flexible plastic fitting at 57 in the manner of a bagpipe where the needle is analogous to the pipe of the bagpipe. FIG. 7 shows the needle 55 in the protected position inside a pocket 59. Pocket 59 includes a tear strip, not shown, which is removed to allow needle 55 to assume the position shown in FIG. 8. In use, a chuck 60 grips the needle as shown in FIG. 9. Once the needle is secured in the chuck, the contents of the bag are easily administered. Unlike this prior art patent, the present invention does not have a separate chuck for administration of the pharmaceutical, nor does the present invention have a rotating needle.
U.S. Pat. No. 5,810,783 is a “Medication Injector” which is a disposable, single use, prefilled unit dose pharmaceutical delivery system; however, the structural design is different from the present invention. To avoid fluid escape during storage, from this prior art patent, the needle 4 is enclosed in a flexible plastic tube 5, closed at its distal end 6 by heat-sealing, to keep air inside the needle 4, acting as a blockage to the fluid. The tube 5 is further enclosed in an air tight envelope 7 as best seen in FIGS. 1A and 2 of this prior art patent. The present invention uses a single cap to shield the needle, unlike this two part shielding system in the '783 Patent.
Owen Mumford Ltd. of Oxon in the United Kingdom advertises a “Snapdragon” single use disposable auto injector. The device is promoted as a single-use, disposable, safety injection device for use with a pre-filled glass syringe. The present invention does not use a pre-filled glass syringe.
Many attempts have been made to produce a single dose disposable pharmaceutical delivery system to replace conventional prefilled syringes; unfortunately none of these attempts have been economically competitive. There remains a need for a reliable unit dose disposable pharmaceutical delivery system that is economical to produce.